产品研发进展 - DBV将采用加速审批途径申请1-3岁幼儿的Viaskin Peanut贴片[1][2][3] - VITESSE III期临床试验在4-7岁儿童中超额完成入组目标，预计2025年第四季度公布结果[9] - 欧洲药品管理局(EMA)的科学建议确认了1-7岁适应症的上市申请注册路径[10] 财务状况 - 公司现金和现金等价物预计将足以支持至2025年第一季度的运营计划[12][14] - 公司正在寻求额外资金以支持Viaskin Peanut的研发和准备上市[14]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________ ____________________ ____________________ Title of each class Trading Symbol(s) Name of each exchange on which registered American Depositary Shares, each representing one ordinary share, nominal value €0.10 per shareDBVT The Nasdaq Stock Market LLC Ordinary shares, nominal value €0.10 per share* n/a The Nasdaq Stock Market LLC * Not for trading, but only in connection with the registration of the American Depositar ...

Châtillon, France, November 6, 2024 DBV Technologies Reports Third Quarter 2024 Financial Results DBV closes Q3 2024 with a cash balance of $46.4 million; cash runway into Q1 2025 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J200), a clinical-stage biopharmaceutical company, today reported financial results for the third quarter of 2024. The quarterly and nine months financial statements were approved by the Board of Directors on November 6, 2024. Financial ...

Châtillon, France, October 22, 2024 DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe DBV to pursue an Accelerated Approval pathway for toddlers ages 1 – 3 years-old BLA submission under Accelerated Approval is subject to completion of a six-month supplemental safety study in toddlers to be initiated in Q2 2025VITESSE Phase 3 study evaluating the Viaskin Peanut patch in children ages 4 – 7 years-old exceeded enrollment goals; Topline results on track fo ...

Châtillon, France, October 18, 2024 DBV Technologies to Participate in Upcoming ACAAI 2024 Congress DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced upcoming participation at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, October 24 – 28th, 2024 in Boston, Massachusetts. This year's meeting will feature a "Product Theater" on What Defines an Optimal Peanut Allergy Treatment? ...

Châtillon, France, September 23, 2024 DBV Technologies Completes Screening for the VITESSE Phase 3 Clinical Trial In Q3 2024, DBV exceeded its recruitment goal and successfully closed the screening process for the VITESSE Phase 3 study evaluating the Viaskin® Peanut Patch in peanut allergic children ages 4 – 7 years old Topline results of VITESSE data are expected by Q4 2025 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today a ...

Châtillon, France, September 4, 2024 DBV Technologies to Participate in the H.C. Wainwright 26th Annual Global Investment Conference DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that Daniel Tassé, Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 26th Annual Global Investment Conference on Monday, September 9, 2024, at 3:00 pm ET, in New York City. A live webcast of the present ...

Information regarding the total number of voting rights and total number of shares of the Company as of July 31, 2024 (Article 223-16 of the General Regulations of the Autorité des Marchés Financiers) Market : NYSE Euronext Paris ISIN Code: FR 0010417345 Date Total number of shares Total number of voting rights 07/31/2024 96,498,927 Total gross of voting rights: 96,498,927 Total net* of voting rights: 96,214,457 * Net total = total number of voting rights attached to shares – shares without voting rights At ...

财务数据和关键指标变化 - 公司在2024年上半年的现金余额为6620万欧元,现金跑道延长至2025年第一季度,这是由于公司实施了成本节约措施 [31] - 2024年上半年,公司的营业收入为260万美元,主要来自于法国的研发税收抵免,此前的与雀巢健康科学的合作协议已终止 [33] - 2024年上半年,公司的营业费用为6500万美元,同比增加28%,其中三分之一为非经常性费用,主要用于维持维生素Peanut的临床试验和CMC活动 [33] - 2024年上半年,公司录得6050万美元的净亏损 [34] 各条业务线数据和关键指标变化 - 公司正在开展维生素Peanut的两个开发项目:一个针对4-7岁儿童的VITESSE III期试验,一个针对1-3岁幼儿的COMFORT Toddlers补充安全性研究 [9][10][11] - VITESSE III期试验已经在美国、加拿大、欧洲、英国和澳大利亚的86个试验点进行,预计将在今年第三季度完成入组 [17][20][21] - COMFORT Toddlers补充安全性研究的方案已于去年11月提交FDA,FDA在今年3月提出了意见,公司一直与FDA就贴片佩戴时间经验等问题进行沟通 [22][23][24] - 公司已于6月28日向FDA提交了一份关于贴片佩戴时间经验的标签建议,并正在等待FDA的反馈 [24][25][26][27][28][29] 各个市场数据和关键指标变化 - 未提及 公司战略和发展方向及行业竞争 - 公司正在开发Viaskin,这是一种基于皮肤免疫疗法(EPIT)的专有技术平台,有广泛的免疫治疗应用潜力,包括食物过敏 [7] - 维生素Peanut是公司最先进的候选药物,正在开发用于1-7岁花生过敏儿童,这个年龄段存在重大的未满足医疗需求,而且免疫系统特别可塑性强 [8] - 公司计划为4-7岁和1-3岁两个年龄段分别提交生物制品许可申请(BLA) [9] 管理层对经营环境和未来前景的评论 - 公司认为FDA的非COVID-19相关积压已经消除,与公司在CMC和临床问题上的互动更加顺畅 [37][38] - 公司期待今年晚些时候公布EPITOPE III期试验的3年结果,并在医学期刊上发表2年结果 [38] 其他重要信息 - 公司的医学事务团队和研究人员、试验点和患者倡导团体等都为VITESSE试验的顺利推进做出了重大贡献 [18][19] 问答环节重要的提问和回答 问题1 **Jon Wolleben 提问** 询问"标签内"和"标签外"的定义是指贴片佩戴时间还是使用体验 [41][42] **Daniel Tassé 和 Pharis Mohideen 回答** 回答"标签内"和"标签外"主要是指贴片佩戴时间的日常变化情况,这反映了患者对局部施加的花生过敏原的敏感程度差异,是一种整体的使用体验 [42][43][44][46] 问题2 **Jon Wolleben 提问** 询问如何量化"标签内"和"标签外"患者的定义 [45][47] **Daniel Tassé 和 Pharis Mohideen 回答** 公司有大量数据可以很好地区分这两类患者,但目前还在与FDA沟通,待最终达成一致后会公开具体的定义和数据 [49][51] 问题3 **Jon Wolleben 提问** 询问COMFORT Children的进展情况以及与COMFORT Toddlers的关系 [52] **Daniel Tassé 回答** COMFORT Children的进展需要先解决COMFORT Toddlers的方案设计,两者是相互关联的 [53]

Châtillon, France, July 30, 2024 DBV Technologies Announces Filing of 2024 Half-Year Report ― Conditions for Accessing or Consulting the Report DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need (the "Company"), today announced the filing, for the semester ended June 30, 2024, of its Half-Year Report with the French m ...